FDA Approval for ORKAMBI issued to VERTEX PHARMS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 206038
Company: VERTEX PHARMS INC
Company: VERTEX PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORKAMBI | IVACAFTOR; LUMACAFTOR | 125MG;200MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| ORKAMBI | IVACAFTOR; LUMACAFTOR | 125MG;100MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/02/2015 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206038Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0206038Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0206038Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/03/2023 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/02/2022 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206038s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206038Orig1s016ltr.pdf | |
| 08/15/2018 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206038Orig1s010Ltr.pdf | |
| 01/25/2018 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206038Orig1s007ltr.pdf | |
| 09/06/2016 | SUPPL-6 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s006ltr.pdf |
| 09/28/2016 | SUPPL-5 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s005ltr.pdf | |
| 08/05/2016 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/2016 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/2016 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/2016 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/02/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206038s016lbl.pdf | |
| 09/02/2022 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206038s016lbl.pdf | |
| 08/15/2018 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s010lbl.pdf | |
| 01/25/2018 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s007lbl.pdf | |
| 09/28/2016 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s005lbl.pdf | |
| 05/18/2016 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s001lbl.pdf | |
| 07/02/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf |